Aflibercept anD navigateD vErsus coNvensional Laser in Diabetic macUlar edeMa

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02554747
• Date of registration: 11/09/2015
• Prospective Registration: Yes
• Primary sponsor: Odense University Hospital
• Public title: Aflibercept anD navigateD vErsus coNvensional Laser in Diabetic macUlar edeMa ADDENDUM
• Scientific title: Aflibercept anD navigateD vErsus coNvensional Laser in Diabetic macUlar edeMa
• Date of first enrolment: October 2015
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02554747
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Denmark

Contacts

• Name: Søren Leer Blindbæk, MD
• Affiliation: Research Unit of Ophthalmology, Clinical Institute, University of Southern Denmark and Department of Ophthalmology, Odense University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diabetes mellitus

- Clinically significant macular edema in the study eye.

- Central retinal thickness > 300 µm in the study eye.

- Best corrected visual acuity 35-80 ETDRS letters (0.10-0.80 Snellen equivalent) in the
study eye.

Exclusion Criteria:

- Pregnancy.

- Active proliferative diabetic retinopathy in the study eye.

- History of cataract surgery, YAG capsulotomy, vitrectomy or retinal laser treatment in
the study eye within 4 months prior to randomization.

- Ocular condition(s) in the study eye that in the opinion of the investigator would
prevent improvement of visual acuity.



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetic Macular Oedema

Intervention(s)

Device: Navigated laser

Device: Conventional laser

Primary Outcome(s)

Percentage of eyes that received additional aflibercept injections after laser at month 12 in group A and B [Time Frame: 1 year]

Secondary Outcome(s)

Evaluation of baseline area of foveal avascular zone (FAZ) as marker of successful treatment outcome at month 12 [Time Frame: 1 year]

Change in level of macular ischemia (area of foveal avascular zone (FAZ)) from baseline to month 12 in group A and B [Time Frame: 1 year]

Change in ETDRS visual acuity from baseline to month 12 in group A and B [Time Frame: 1 year]

Change in macular retinal vessel geometric markers from baseline to month 12 in group A and B [Time Frame: 1 year]

Change in global oxygen saturation from baseline to month 12 in group A and B [Time Frame: 1 year]

Change in global retinal vessel geometric markers from baseline to month 12 in group A and B [Time Frame: 1 year]

Change in macular oxygen saturation from baseline to month 12 in group A and B [Time Frame: 1 year]

Number of additional aflibercept injections after laser at month 12 in group A and B [Time Frame: 1 year]

Evaluation of non-invasive retinal risk factors (retinal vascular geometric markers and oxygen saturation) for successful treatment outcome at month 12 [Time Frame: 1 year]

Secondary ID(s)

S-20150077

SDUSF-2015-21-(129)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Moorfields Eye Hospital NHS Foundation Trust